Bank Quality Assurance Specialist (Healthcare Scientist) Band 8A

Job responsibilities

Royal Free World Class Values

The post holder will offer World Class Care to service users, staff, colleagues, clients and patients alike.

1. RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT

To deliver the key targets for the Trust research and development agenda as agreed between the post holder and the Head of Pharmaceutical Quality

To ensure the pharmaceutical quality management system is maintained and developed in accordance with the ML (specials) and MA (IMP) license requirements and in response to changes in regulations and legislation.

To participate in the GMP Internal Audit / self-inspection programme. ensuring audits are conducted, reported and CAPA managed in a timely manner.

To ensure QA requirement for validation master plan are fully completed and documented.

To assist in the review of service contracts and technical agreements with suppliers.

To assist in the review of specifications for raw materials, finished products, packaging materials and labels.

2.Staff Supervision and Training

To participate in the training of Pharmacists, scientists, pre-registration pharmacy graduates, Pharmacy Technicians and student Pharmacy Technicians. Training of personnel external to the trust may also be required.

3.Resource Management

To assist in the planning for equipment procurement and ensure that equipment and plant is adequately qualified and maintained and its performance continuously verified.

4.Research and Development (including Clinical Trials)

To provide support to the development, formulation and validation of new products in response to clinical trial and clinical need and risk management in accordance with client and trust objectives.

To undertake, supervise and give guidance on the preparation of pharmaceutical clinical trial materials used within the Trust.

To review all new trial documentation and assess whether the production of the Investigational medicinal product (IMP) comes under the MA (IMP) license, or is subject to preparation in accordance with exemptions specified in Regulation 37 of the Clinical Trial regulations (SI2004/1031). To ensure that all IMP production and preparation is undertaken in compliance with GMP and GCP

5.CLINICAL SERVICES

To provide expert pharmaceutical QA advice on the use of all the trusts manufactured products.

To assess the suitability of unlicensed medicines purchased by the trust and release for use as appropriate.

6.PROFESSIONAL RESPONSIBILITIES

To remain on the relevant Professional register.

To undertake GCP and GMP training as required.

To maintain 100% MAST record.

To act as a role model to all other Pharmacy staff.

To participate in regional training initiatives for manufacturing, preparation, dispensing and QA where applicable.

To always behave in a manner that is professional, positive and polite.

To be accountable for own professional actions.

To maintain awareness of current developments in pharmacy, Radiopharmacy safety, human resources and employment law.

For further information please refer to the attached JD and PS

VISA SPONSORSHIP DOES NOT APPLY TO THIS ROLE

Royal Free World Class Values

Essential

• Demonstrable ability to meet the Trust Values

Education & Professional Qualifications

Essential

• Full membership of a relevant Professional Body
• Mandatory CPD to maintain fitness to practice

Desirable

• Pharmacist or relevant Science degree
• Further qualification in relevant technical or management area
• European Computer Driving Licence

Others

Essential

• Excellent verbal and written communication and presentation skills suitable for a range of audiences.
• Experienced in giving presentations to diverse audiences.
• Able to act as an Ambassador for the Service
• Able to perform the duties of the post with any aids and adaptations
• Required to wear specialised clean room clothing and safety equipment
• Effective time management
• Effective team worker

Skills and Aptitudes

Essential

• Demonstrated ability to identify problems, analyse root cause and propose solutions for complex problems
• Demonstrated expert technical knowledge of G(QC)LP and GMP, and a proven ability to apply this knowledge to maintain, develop and validate quality systems
• Demonstrated Project Management Skills
• Demonstrated ability to manage out of specification results and incidents and develop and review action plans to resolve these
• Able to communicate effectively with all healthcare professionals and colleagues orally and in writing.
• Able to identify and manage risk
• Able to solve difficult and ambiguous problems by advanced reasoning and sound technical judgement
• Able to deliver and validate staff training
• Able to manage non compliances and incidents and develop and review action plans to resolve them
• Able to prepare and complete documentation accurately with attention to detail, even when under pressure
• Able to work effectively in stressful situations
• Demonstrated ability to perform complex calculations accurately
• Able to plan, prioritise and organise self
• Able to plan, prioritise and organise the work of others
• Able to meet deadlines
• Able to work unsupervised
• IT skills including use of email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes
• Demonstrated effective customer service skills
• Critical Appraisal skills
• Able to follow local Manual Handling procedures
• Demonstrated evidence of the safe handling of hazardous materials

Experience

Essential

• Proven experience of good performance in previous jobs
• Extensive experience in pharmaceutical manufacturing, including experience in a large licensed facility.
• Experience of managing & motivating staff
• Experience of training and supervising staff
• Demonstrated experience & ability to successfully supervise and undertake a range of technical projects
• Demonstrated expert technical knowledge covering Pharmaceutical QA, and Production
• Knowledge of all aspects of cGMP, and current legislation and regulations and ability to apply this knowledge to support QA services
• Demonstrated knowledge of principals and practices of aseptics / parenterals e.g. formulation, stability, administration, legal issues
• Knowledge of COSHH, and health and safety at work
• An awareness of current national standards, guidelines and service delivery issues relevant to Technical Services and ability to apply these to Quality Services
• Demonstrated knowledge of cGMP, G(QC)LP and PQS
• Demonstrated knowledge of Validation requirements of pharmaceutical facilities and Audit
• Demonstrated knowledge of Pharmaceutical microbiology and Contamination Control

Desirable

• Experience in a QC Laboratory linked to a MHRA Licensed Pharmacy Manufacturing Unit
• Previous experience in the design, development and undertaking of stability studies
• Previous experience in validation of pharmaceutical manufacturing processes
• Understanding and experience of medicines reconciliation

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).